FDAJanuary 11, 2024device
Colonoscope, Model Number PCF-H190L.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
What to do
FDA enforcement status: Ongoing
Brands named
olympus
UPCs
04953170305191
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21122026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21112026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.2026-03-25
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